- Rx for the Pharmaceutical Industry:Call Your Doctors
Pharmaceutical companies are guilty of moral misconduct. They stretch the definitions of illnesses, such as bipolar disorder, in order to expand markets.1 They sponsor seeding studies, such as Merck's ADVANTAGE trial (Assessment of Differences between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness), in order to facilitate the rapid uptake of a new drug at the time of its launch.2 They promote unapproved uses of drugs, such as Lilly's "Viva Zyprexa" campaign, in which sales representatives recommended the drug for dementia.3 These activities all aim to maximize sales.
Yet drug companies have translated scientific discoveries into products that have improved and extended the lives of millions of people. For example, statins prolong survival in patients with coronary artery disease,4 tumor necrosis factor inhibitors retard joint destruction in patients with rheumatoid arthritis,5 and imatinib induces remission in most patients with chronic myeloid leukemia.6 Sometimes alone and sometimes in collaboration with investigators from academia or government, the pharmaceutical industry has helped people live longer, better lives.
Drug companies are also a source of crucial research funding. The U.S. pharmaceutical industry invested $47.9 billion in research and development in 2007.7 If the current level of productivity and investment from the private sector is to continue without repeating the pitfalls of the past, we must collaborate with industry to find better ways of ensuring ethical drug development. Multiple changes will be necessary to achieve this end. External reforms so far have come from the government,8 academia,9 and journal editors.10 Internal ethics initiatives have also been introduced at several companies.11 For example, Roche established an external Science and Ethics Advisory Group.12 Merck and Abbott have established ethics offices.13 GlaxoSmithKline, Lilly, Merck, and Abbott maintain confidential "helplines" that employees may call to report potential violations.14 The industry deserves credit for taking these steps. Whether they actually have a positive impact or serve simply as window-dressing intended to disarm critics remains to be seen. What else can be done to bridge the gap between the industry's key role in producing important products and the parade of unethical actions that plague it?
As a physician and a former vice-president of Pfizer, I believe that a previously unrecognized way of addressing the problem may already exist inside the pharmaceutical industry itself, in the form of the physicians who work there. In order for industry physicians to ensure ethical behavior, it is necessary that they: 1) make decisions about ethical issues; 2) acknowledge they have a moral duty to ensure that their company behaves ethically; 3) possess the knowledge and skills required to perform their jobs; 4) have the responsibility and the incentive to conduct clinical research ethically, rather than just to increase revenue; and 5) work in a culture that recognizes and supports their expertise and their role.
Roles and Obligations of Physicians in Industry
Approximately eighty-six thousand medical and scientific professionals work in drug companies in the United States.15 Pharmaceutical physicians are deployed throughout the industry in many positions—as bench researchers, focusing on the discovery of new drugs; as clinical researchers, designing, implementing, and overseeing phase I–IV trials; and as safety experts, focusing on "pharmacovigilance," which refers to monitoring the side effects of a drug. Others compile medical information, review promotional materials, create speakers bureaus, and review independent medical grants. Many work with marketers and other colleagues to create product development plans, launch new products, and implement strategies to support approved compounds.
Given the diversity of jobs carried out by physicians in industry, it is not surprising that they participate in making many ethically laden decisions, ranging from the selection of disease targets to the proper conduct of trials in the third world to the monitoring and management of potential safety issues. Physicians in industry are in the thick of ethical conflicts in drug development and therefore well positioned to prevent them.
Simply being in the right spot at the right time is not enough, though. Physicians in industry must realize that they have an obligation to ensure ethical conduct...